Development of an Adjustment Assistance Tool Dosage of Fluoroquinolones in a Population Pharmacokinetic Model (FLUO-POP)

May 22, 2023 updated by: Rennes University Hospital

Fluoroquinolones (FQ) are among pivotal antibiotic treatments in difficult-to-treat infections. Their efficacy has been shown to be linked to the ratio area under the curve (AUC) of their plasma concentrations over the minimum inhibitory concentration (MIC) of the bacteria treated. Eventually, Forrest et al., reported in gram-negative infections that an AUC/MIC above 125 conducted to a 80 to 90% clinical success whereas success decrease to 30 to 40% in patients with an AUC/MIC below this threshold. These results have been reproduced recently by Zelenitsky et al. in intensive care unit (ICU) patients with threshold similar to the one obtained by Forrest et al. Lastly, elevated concentrations of FQ should be related with the onset of adverse events. Thus, therapeutic drug monitoring (TDM) of FQ appears of potential interest, particularly in case of severe infections (intensive care unit (ICU) patients) or complicated and cost-related infections (osteoarticular infected (OAI) patients), with an increasing level of evidence of its use.

However, FQ TDM requires access to the full AUC of the drug with the need of many samples drawn to patients. This appears to be irreconcilable with clinical practice but can be achieved using population pharmacokinetic (PkPop) modelling. PkPop allows estimating pharmacokinetic parameters of the drug by introducing covariates (demographic, biological, clinical…) and modelling inter-individual pharmacokinetic variability. The model created allows then accessing to individual parameters of patients and thus, estimating concentrations and AUC of the FQ. This approach may also be used in clinical practice to determine a limited sampling strategy allowing an adequate estimation of AUC with a minimum of samples.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open, prospective, monocentric pharmacokinetic study

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Rennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age over 18 years
  • Patients in intensive care : Infection treated with ciprofloxacin IV
  • Osteoarticular infected patients : infection treated with oral ofloxacin
  • Written consent to participate in the study

Exclusion Criteria:

  • Pregnancy
  • Adults subject to legal protection or deprived of their liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients in intensive care
30 patients in intensive care treated with ciprofloxacin IV
Drug: Patients in intensive care : infection treated with ciprofloxacin IV
8-10 samples per patients on day-4 of their treatment
Other Names:
  • Blood samples
Experimental: Osteoarticular infected patients
30 patients in orthopedics treated with oral ofloxacin
Drug: Osteoarticular infected patients : infection treated with oral ofloxacin
8-10 samples per patients on day-4 of their treatment
Other Names:
  • Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentration measurement of ciprofloxacin and ofloxacin
Time Frame: on day-4 of their treatment (steady-state)
measurement between 2 administrations (8-10 samples per patients)
on day-4 of their treatment (steady-state)

Secondary Outcome Measures

Outcome Measure
Time Frame
Demographic data
Time Frame: on day-4 of their treatment (steady-state)
on day-4 of their treatment (steady-state)
Biological data
Time Frame: on day-4 of their treatment (steady-state)
on day-4 of their treatment (steady-state)
Clinical data
Time Frame: on day-4 of their treatment (steady-state)
on day-4 of their treatment (steady-state)
AUC
Time Frame: on day-4 of their treatment (steady-state)
on day-4 of their treatment (steady-state)
MIC
Time Frame: on day-4 of their treatment (steady-state)
on day-4 of their treatment (steady-state)
Cmax
Time Frame: on day-4 of their treatment (steady-state)
on day-4 of their treatment (steady-state)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Bruno BL Laviolle, MD/PhD, Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-004193-4
  • 35RC14_9179 (Other Identifier: CHU Rennes)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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